Medicine
Magnesium sulfate 4000 mg/100 mL injection
Magnesium sulfate 4000 mg/100 mL injection is a generic prescription medicine for intravenous use, made by 11 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Protect from freezing. Store at 20° to 25°C (68 to 77°F).
Key facts
- Active ingredient (INN)
- Magnesium sulfate
- Brand
- Sold under the generic name
- Strength
- 4000 mg/100 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 24 pouches of 100 mL, 12 pouches of 100 mL, 24 containers of 100 mL and 10 more
- Manufacturers
- Gland PharmaIndiaSun Pharmaceutical IndustriesIndiaAmneal PharmaceuticalsHospiraAthenex Pharmaceutical DivisionAvenacyB. Braun MedicalBaxter HealthcareFresenius KabiSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 20° to 25°C (68 to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A06AD04 Magnesium sulfate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 August 2005
- Identifiers
- RxCUI 1658259, 1658262, 829734 +3DailyMed set ID efadcb55-f935-4c60-b2e2-0a76b9194b50, 752f55bb-c4ca-4545-94b3-3deea66888d4, ea05b8f9-6e11-45c3-824a-4a78818019df +8NDC 47335-992, 44567-421, 0338-1715 +9Application ANDA213917, ANDA207350, ANDA211966 +5
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 24 pouch in 1 case / 1 bag in 1 pouch / 100 mL in 1 bag | 68083-397-01 | Gland PharmaIndia | 10 July 2020 |
| 24 pouch in 1 case / 1 bag in 1 pouch / 100 mL in 1 bag | 47335-992-02 | Sun Pharmaceutical IndustriesIndia | 1 August 2021 |
| 24 pouch in 1 case / 1 bag in 1 pouch / 100 mL in 1 bag | 0409-4121-24 | Hospira | 24 August 2026 |
| 24 pouch in 1 case / 1 bag in 1 pouch / 100 mL in 1 bag | 0409-6729-23 | Hospira | 13 October 2005 |
| 12 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 70121-1720-3 | Amneal Pharmaceuticals | 8 January 2024 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 70121-1720-9 | Amneal Pharmaceuticals | 20 February 2023 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 70860-501-82 | Athenex Pharmaceutical Division | 31 January 2023 |
| 24 container in 1 case / 100 mL in 1 container | 0264-4206-54 | B. Braun Medical | 26 April 2021 |
| 40 bag in 1 carton / 100 mL in 1 bag | 0338-1715-40 | Baxter Healthcare | 1 June 2020 |
| 24 bag in 1 case / 100 mL in 1 bag | 63323-106-01 | Fresenius Kabi | 15 March 2016 |
| 10 bag in 1 carton / 100 mL in 1 bag | 25021-612-82 | Sagent Pharmaceuticals | 15 February 2021 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 44567-421-24 | WG Critical Care | 9 January 2018 |
| 24 pouch in 1 carton / 1 bag in 1 pouch / 100 mL in 1 bag | 83634-500-82 | Avenacy | 22 April 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 8 September 1986 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Magnesium sulfate
Clinical summary
Magnesium sulfate is a calculi dissolution agent indicated for the prevention and control of seizures in a pre-eclampsia and eclampsia, respectively. It is available as injection for intravenous and intramuscular use. MedsAcross supplies Magnesium sulfate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Magnesium sulfateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Magnesium Sulfate prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Magnesium sulfate 4000 mg/100 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.